The vaccine has been approved in Europe for prevention of smallpox since 2013, although has been used off-label against monkeypox. It is already approved for both smallpox and monkeypox in the US and Canada (where it is known as Jynneos and Imvamune respectively).
The approval follows a positive opinion issued by the European Medicine Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday, and is valid in all EU Member States as well as in Iceland, Liechtenstein, and Norway.
'Great cooperation' helps speed up regulatory process
The CHMP based its recommendation on data from several animal studies which showed protection against the monkeypox virus in non-human primates vaccinated with Imvanex. The CHMP considered that the effectiveness of Imvanex in the prevention of monkeypox disease in humans could be inferred from these studies.
Previous generations of vaccines against smallpox have been estimated to be around 85% effective against monkeypox, based on data collected in Africa in the 1980s.
To confirm the effectiveness of the vaccine against monkeypox, Bavarian Nordic will collect data from an observational study that will be carried out during the ongoing monkeypox outbreak in Europe.
While a label extension application of this type can be expected to take six to nine months in the EU, the company and European regulators says 'great collaboration' in the face of the monkeypox outbreak allowed approval to be granted in less than two months.
The EC has approved the full Imvanex indication as ‘active immunisation against smallpox, monkeypox and disease caused by vaccinia virus in adults.’
The vaccine was originally developed in collaboration with the US government as part of national biological preparedness plans against smallpox. However, the similarity of the monkeypox virus and smallpox virus means the vaccine is now first-in-line as a defense against the current monkeypox outbreak.
Bavarian Nordic continues to sign contracts for Imvanex/Jynneos, including one with the EU for 110,000 doses this year and other individual contracts with undisclosed European countries.
Paul Chaplin, President and CEO of Bavarian Nordic said: “We are pleased to receive the approval from the European Commission, broadening the label of our vaccine to include monkeypox. The availability of an approved vaccine can significantly improve nations’ readiness to fight emerging diseases, but only through investments and structured planning of the biological preparedness.
"The development of Imvanex was made possible through significant investments from the US government for the past two decades, leading the way for other governments to develop plans and prioritize for the future to protect their citizens against public health threats. With this approval, we look forward to working closer with the EU and its member states to solve this important task.”
The World Health Organization has now declared the monkeypox outbreak as a global health emergency, the highest alert it can issue. One of the key concerns is that little is known about the new modes of transmission which have caused cases to spread.
More than 16,000 cases have now been reported from 75 countries, with five deaths recorded as a result of the outbreak.
